All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. MR imaging provides excellent spatial . Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729802976 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 021717889 * Terms of Use Device Description: Ureteral Stent CLOSE Device Characteristics Device Record Status Alternative and Additional Identifiers Customer Contact [?] Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. By using this site, you consent to the placement of our cookies. The Epic Stent is compatible with 6F sheaths, and the stent delivery system is compatible with 0.035 inch guidewires. Boston Scientific is recalling the VICI SDS and RDS VENOUS STENT Systems after reports indicate that the stents may migrate or move from where they are initially implanted. NATICK, Mass., Oct. 23, 2012 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) reports twelve-month clinical endpoint data from the ORION trial, which demonstrated robust safety and effectiveness outcomes for the Epic Self-Expanding Nitinol Stent System in patients with obstructed iliac arteries. The trial previously met its primary endpoint of major adverse events (MAE) at nine months with a rate of 3.4 percent for the Epic Stent compared to a pre-specified performance goal. Boston Scientific, www.bostonscientific.com, Neuroform Atlas Stent Non-clinical testing and analysis have demonstrated that the Neuroform Atlas Stent is MR Conditional alone, or when overlapped with a second stent, and adjacent to a Stryker Neur, AAA Endograft Ovation Ovation Abdominal Stent Graft System TriVascular2, Inc. Santa Rosa, CA, Abre StentMedtronic, Inc., www.Medtronic.com/MRI, Absolute .035 Biliary Self-Expanding StentAbbott Vascular, www.abbottvascular.com, ABSOLUTE 0.35 Biliary Self Expanding Stent System Guidant http://www.guidant.com/ifu/, Absolute Biliary StentAbbott Vascularwww.abbottvascular.com, Absolute Pro .035 Biliary Self-Expanding StentAbbott Vascular, www.abbottvascular.com, Absolute Pro Peripheral Stent Abbott Vascular www.Abbott.com, Absolute Pro Stent Nickel titanium with nickel titanium platinum markers 8-mm x 120-mm Single version Abbott Vascular Santa Clara, CA, Absolute Pro Stent Nickel titanium with nickel titanium platinum markers 8-mm x 348-mm three overlapped version Abbott Vascular Santa Clara, CA, ABSOLUTE Biliary Self-Expanding Stent System Nitinol coils, filters, stents Guidant Endovascular Solutions Santa Clara, CA, Absorb Bioresorbable Vascular Scaffold (BVS) SystemAbbott Vascular, www.abbottvascular.com, Absorb GT1 Bioresorbable Vascular Scaffold (BVS) SystemAbbott Vascular,www.abbottvascular.com, Acculink Carotid StentAbbott Vascularwww.abbottvascular.com, ACCULINK Carotid StentGuidanthttp://www.guidant.com/ifu/, ACS MULTI-LINK Coronary StentAbbott Vascularwww.abbottvascular.com, ACS MULTI-LINK DUET Coronary StentAbbott Vascularwww.abbottvascular.com. MRI safety testing has shown that the REBEL Stent is MR Conditional and that Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors. THE List - MRI Safety Search for coronary and peripheral disease and valve disease IFUS. Abbotts MRI-Ready High Voltage Device Setup for Gallant and Entrant ICD and CRT-Ds (11:45). Search for arrhythmia, heart failure and structural heart IFUs. Results were presented today by Daniel Clair, M.D., FACS, principal investigator of the ORION trial and chairman of the Department of Vascular Surgery at The Cleveland Clinic Foundation, at the 24th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation. endstream endobj 60 0 obj <>>>/Filter/Standard/Length 128/O(v~aIgInj rM)/P -1340/R 4/StmF/StdCF/StrF/StdCF/U( ey,62_ )/V 4>> endobj 61 0 obj <>>> endobj 62 0 obj <> endobj 63 0 obj <>/ExtGState<>/Font<>/ProcSet[/PDF/Text]/Properties<>/Shading<>/XObject<>>>/Rotate 0/TrimBox[24.0 24.0 619.276 865.89]/Type/Page>> endobj 64 0 obj <>stream 2*Uax?t} %PDF-1.4 % 1.5,3: Conditional 5 More . If a device is not shown in the list, it is not MR Conditional. These forward-looking statements include, among other things, statements regarding our business plans, clinical trials and outcomes, our technology, product performance and importance, and competitive offerings. A stent delivery system for a balloon expandable stent consists (,OcEh{[%E#Xl@::9(k]xv# q#fs+[Jb{-$r;EB9 pdRkEdq^(PFG3|'ae1wsv4N5:YBswO[kQC9U0EJ[Tkd/*4s3_SN}W~jj,SPuT-9 )44ZtGtWAO@Fo aP3lqS-P*)v"rj5QEWL!zg8KbORyvm?B'tZ&3D#>7"7Q8&a*$"xmVTeV [@[@.o)BpiyHpV1FIh\w|wD!2N^# U#gb a]qkz,'@Ri3 If needed, perform capture and sense and lead impedance tests. All other trademarks are the property of their respective owners. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. Upon approval, the Epic Stent along with the market-leading Express LD balloon-expandable iliac stent, would enable Boston Scientific to offer a complete line of advanced iliac solutions for physicians and patients." It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and may be inserted with a balloon catheter which causes the device to expand when inflated, or it may self-expand after insertion with a delivery device. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. The delivery system is of coaxial design with an exterior shaft to protect and constrain the stent prior to deployment. Newmatic Medical, www.newmaticmedical.com. Paul, M, Esophageal Reconstruction TubeHood Laboratories, www.hoodlabs.com, Esophageal Stent, Niti-S & Comvi Model E2423TaeWoong Medical Co., Ltd., www.stent.net, Esophageal StentHood Laboratories, www.hoodlabs.com, Esophageal TTS StentTaeWoong Medical Co., Ltd., www.stent.net, Esophagus Full-Covered StentCG BIO CO., LTD. www.cgbio.co.kr/en/. Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral Products PDF, 272.0 KB. (0.89mm) guidewires. Coronary data supports safety of paclitaxel and ELUVIA DES IV. PDF Summary of Safety and Effectiveness Data WALLSTENT with Unistep Drummond wire (316L SS) orthopedic implant. The ORION clinical data was used to support application for U.S. Food and Drug Administration approval of the Epic Stent System. On April 12, 2021, Boston Scientific Corporation sent an Urgent Medical Device Recall Notification to customers asking them to: Customers with questions should contact their Boston Scientific sales representative. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Use of these devices may cause serious injuries or death. CAUTION: These products are intended for use by or under the direction of a physician. The Merlin PCS Programmer will print to the default printer (internal printer, external printer or PDF). This cautionary statement is applicable to all forward-looking statements contained in this document. Results were presented today by Daniel Clair, M.D., FACS, principal investigator of the . Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. To look up your patient's system, use the Product Search tool to determine whether your patient's device and leads (if applicable) are safe for an MRI. Device Size Text, specify: 75 cm Effective Length, Device Size Text, specify: 40 mm Stent Length, Device Size Text, specify: 10 mm Stent Diameter. 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Boston Scientific's Express 2 (bare-metal) stent system also received approval for immediate MRI exams. NOTE: Device diagnostic data may be suspended or cleared when MRI Settings are enabled. Overview of the ELUVIA Drug- Eluting Stent (DES) III. Introduction II. Enterra II Model 37800Gastric Electrical Stimulation (GES) SystemEnterra II Model 37800Medtronic, Inc., www.medtronic.com, Enterra TherapyGastric Electrical Stimulation (GES) SystemModels 3116 and 7425 GEnterra II Model 37800Medtronic, Inc., www.medtronic.com, Entovis ProMRI Cardiac Pacing SystemWhich consists of the Entovis pulse generator and the Setrox S and Safio S leadsBIOTRONIK, Inc., http://www.biotronikusa.com/manuals/index.cfmNote that the MR Condi, ENTRI-FLEXEntriFlexNasogastric (NG) Feeding TubeCOVIDIENHazelwood, MO, ENTRISTARJejunum Feeding Tube/Gastric Depression TubeCOVIDIENHazelwood, MO, EOI Spinal System EPPS (Expanding Polyaxial Pedicle Screw)Expanding Orthopedics Inc.Israel, EOS (Endoluminal Occlusion System) ImplantMedical Murray, Inc., medicalmurray.com, Epic StentBoston Scientific, www.bostonscientific.com, EpicageAlphatec Spine Inc., www.alphatecspine.com, Episealer Knee CondyleEpisurf Medical AB, www.episurf.com, Equi-Flow Valve System(s)15174, SLRKL, SLSKLL, 15175, SLRKLL,SLSKLM, 15179, SLRKLM, SLSKM, 15185,SLRKM, SLSL, 15549, SLRL, SLSLL,15551, SLRLL, SLSLM, 15552, SLRLM,SLSM, 15554, SLRM, 15181, 15555,SLSKL, Equine Pericardial Patch, Model XAGEdwards Lifesciences, www.edwards.com, EquipLite bladeTruphatek International LTD., www.truphatek.com, ES-830 MicroCutter Green StapleCardica, Inc. and Dextera Surgical, www.dexterasurgical.com, EsophaCoil-SRnitinolcoil, stent, filterIntratherapeutics, Inc.St.